Allarity Therapeutics has worked diligently to develop Novartis’ failed cancer drug dovitinib. Now, as the Danish biotech anticipates the drug’s approval for metastatic renal cell carcinoma, it has lined up a manufacturing partner.
Allarity has come to an agreement with CDMO giant Lonza, which will provide drug supply and regulatory support toward potential commercialization.
From its facility in Visp, Switzerland, Lonza will perform drug substance manufacturing and particle size reduction by micronization. Product manufacturing will take place at Lonza’s plant in Tampa, Florida. Production will begin in 2022, the partners said.
For Lonza, the news comes during a period of rapid expansion. Earlier this week, the Swiss company unveiled an investment in its plant close to home in Stein which will add 70 employees and an aseptic filling line for clinical drug supply.
Last month, Lonza said it was adding a new fill-finish line at its biologics facility in Guangzhou, China. In May, the company pledged $935 million to build mammalian facilities at its complexes in Portsmouth, New Hampshire, and Visp, Switzerland.
Dovitinib, a small-molecule, pan-tyrosine kinase inhibitor, is Allarity’s lead clinical asset. The company hopes to apply the drug for other indications including liver cancer, breast cancer and various solid tumors.
“Entering this agreement with Lonza is an important step in our long-term preparations to take dovitinib toward commercialization,” Allarity CEO Steve Carchedi said in a statement.
In 2018, Oncology Venture obtained dovitinib from Swiss drug giant Novartis. Two years later, the company changed its name to Allarity Therapeutics, reshuffled its board of directors and declared a shift in focus toward U.S. commercialization.
Earlier this month, at the European Society for Medical Oncology conference, Allarity presented data showing that renal cell carcinoma patients selected with a dovitinib drug response predictor (DRP) diagnostic tool had a median survival rate of 15 months. That compared with 11.2 months for those treated with Bayer's Nexavar.
All of Allarity’s pipeline medicines, including five mid- to late-stage cancer candidates, are being developed with a DRP diagnostic tool. The company said it expects the dovitinib DRP to receive premarket approval this year.